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IMODIUM COMPLETE is a brand name for Simethicone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: IMODIUM® Complete (Loperamide Hydrochloride and Simethicone) is indicated: • as an adjunct to rehydration therapy for the symptomatic control of acute, nonspecific diarrhea associated with gas-related abdominal discomfort, such as distention, bloating, flatulence, abdominal pain and cramping. Treatment of diarrhea…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • IMODIUM® Complete should be used with special caution in children under 12 years of age because of greater variability of response and possible difficulty of swallowing. • Hepatic Impairment: Although no pharmacokinetic data are available in patients with hepatic impairment, IMODIUM® Complete should be used with caution in such patients because of reduced first pass metabolism.
(see Warnings and Precautions). 2 Recommended Dose and Dosage Adjustment Adults and children 12 years of age and older: Swallow 2 IMODIUM® Complete after the first loose bowel movement and one caplet after each subsequent loose bowel movement, up to a maximum of 4 caplets a day for no more than 2 days.
Children 6-11 years of age:
IMODIUM® Complete is not recommended for children under 12 years of age except on the advice of a physician.
The proposed dose that may be used:
Swallow 1 IMODIUM® Complete Caplet after the first loose bowel movement and ½ caplet after each subsequent loose bowel movement, up to a maximum 3 caplets (for ages 9- 11 years) or maximum 2 caplets (for ages 6-8 years) per day, for no longer than 2 days.
Geriatrics (> 65 years of age):
No dose adjustments are required for the elderly.
Renal Impairment:
No dosage adjustment necessary in renal impairment. 4 Administration IMODIUM® Complete should be taken by mouth and can be taken at any time of day. The caplets should be taken with a full (250 mL) glass of water. Drink plenty of clear fluids to help prevent dehydration which may accompany diarrhea.
Take only on an empty stomach (1 hour before or 2 hours after a meal).
Product Monograph Master Template Template Date:
September 2020 IMODIUM® Complete Loperamide Hydrochloride / Simethicone Tablets Page 6 of 26 Unclassified / Non classifié
The standard for defining frequency terms will be based on the Council for International Organizations of Medical Science (CIOMS) convention. 1 Adverse Reaction Overview With use of loperamide hydrochloride, occasional hypersensitivity reactions have been reported, such as skin rash and urticaria, and extremely rare cases of anaphylactic reaction (including anaphylactic shock) and bullous eruption including Toxic Epidermal Necrolysis.
In the majority of these cases, the patients were on other medications which may have caused or contributed to the events.
Product Monograph Master Template Template Date:
September 2020 IMODIUM® Complete Loperamide Hydrochloride / Simethicone Tablets Page 10 of 26 Unclassified / Non classifié The adverse effects reported in adults during clinical trials with Loperamide hydrochloride/Simethicone Chewable Tablets were generally of a minor and self-limiting nature and infrequent: nausea, altered taste (<2%); headache, chills, dry mouth, cough, skin rash (<1%); constipation (<1%) and/or abdominal distension have also been reported.
In some very rare cases, particularly in which the treatment information had not been respected, these latter effects have been associated with ileus (including paralytic ileus). Urinary retention has been reported rarely. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying andapproximating rates of adverse drug reactions in real-world use.
0% or greater as measured in Clinical Trials. 0% or greater or classified as “common”, which was more frequently reported in patients on placebo than on loperamide/simethicone, was: dizziness. 5 Post-Market Adverse Reactions Loperamide/Simethicone is a combination product containing loperamide hydrochloride.
General If clinical improvement is not observed within 48 hours, the administration of Loperamide hydrochloride/Simethicone should be discontinued and patients should be advised to consult their physician. In case of accidental ingestion of Loperamide hydrochloride/Simethicone by children, see OVERDOSE section.
The use of higher than the recommended doses for control of the diarrhea may lead to abnormal heart rhythms and serious cardiac events leading to death. Tiredness, dizziness, or drowsiness may occur in the setting of diarrheal symptoms treated with loperamide.
Therefore, it is advisable to use caution when driving a car or operating machinery. Abuse and misuse, as an opioid substitute, have been described in individuals with opioid addiction. Dependence/Tolerance Physical dependence to loperamide hydrochloride in humans has not been observed at the recommended dosage.
Upon cessation, cases of drug withdrawal syndrome have been observed in individuals abusing, misusing, or intentionally overdosing with excessively large doses of loperamide (see OVERDOSAGE section). Studies in morphine-dependent monkeys demonstrated that loperamide hydrochloride at doses above those recommended for humans prevented signs of morphine withdrawal.
However, in humans, the naloxone challenge pupil test, which when positive indicates opiate-like effects was negative, when performed after a Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Caplets / Loperamide Hydrochloride, 2 mg & Simethicone, 125 mg acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavour, maltodextrin, microcrystalline cellulose, propylene glycol, stearic acid Product Monograph Master Template Template Date: September 2020 IMODIUM® Complete Loperamide Hydrochloride / Simethicone Tablets Page 8 of 26 Unclassified / Non classifié single high dose, or after more than two years of therapeutic use of loperamide hydrochloride.
• Loperamide hydrochloride/Simethicone is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 Dosage Forms, Strengths, Composition and Packaging section of the product monograph.
• Loperamide hydrochloride/Simethicone is contraindicated for use in children under 2 years of age. • Loperamide hydrochloride/Simethicone is contraindicated in those in whom constipation must be avoided. • Loperamide hydrochloride/Simethicone should not be used in the case of acute dysentery that is characterized by blood in stools and elevated temperature.
Fluid and electrolyte depletion may occur in patients who have diarrhea. The use of Loperamide hydrochloride/Simethicone does not preclude the administration of appropriate fluid and electrolyte therapy.
Product Monograph Master Template Template Date:
September 2020 IMODIUM® Complete Loperamide Hydrochloride / Simethicone Tablets Page 5 of 26 Unclassified / Non classifié • Loperamide hydrochloride/Simethicone should not be used in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter.
• Loperamide hydrochloride/Simethicone must not be used in patients with acute ulcerative colitis or pseudomembranous colitis associated with broad-spectrum antibiotics. In such patients, agents which inhibit intestinal motility or delay intestinal transit time have increased the possible risk of significant sequelae including ileus, megacolon and toxic megacolon.
Loperamide hydrochloride/Simethicone therapy should be discontinued promptly if abdominal distention occurs or if untoward symptoms develop. In general, Loperamide hydrochloride/Simethicone should not be used when the inhibition of peristalsis is to be avoided.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Simethicone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Therefore, adverse experiences considered significant for loperamide hydrochloride will also be included in this section due to the theoretical expectation of a similar adverse event profile even in the absence of actual reports for Loperamide/Simethicone.
Adverse events which may be causally related to the administration of Loperamide/Simethicone that have come to light as a result of reports received in relation to administration of the marketed product are provided in this section.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders:
Allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic reaction, anaphylactic shock and anaphylactoid reactions have been reported for loperamide hydrochloride.
Nervous System Disorders:
Dizziness, loss of consciousness, coordination abnormality, hypertonia, stupor and depressed level of consciousness have been reported for loperamide hydrochloride.
Eye Disorders:
Miosis has been reported for loperamide hydrochloride.
Gastrointestinal Disorders:
Abdominal pain/abdominal pain upper, nausea, constipation, flatulence, vomiting and dyspepsia. Abdominal distension, ileus (including paralytic ileus) and megacolon including toxic megacolon have been reported for loperamide hydrochloride (see PRECAUTIONS).
Renal and Urinary Disorders:
Urinary retention has been reported for loperamide hydrochloride Psychiatric System Disorders: Drowsiness Skin and Subcutaneous Tissue Disorders: Rash, urticaria and pruritus. Angioedema, and bullous eruptions including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis have been reported for loperamide hydrochloride.
Special Senses:
Dysgeusia A number of the adverse events reported during the clinical investigations and post-marketing experience with loperamide are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence).
These symptoms are often difficult to distinguish from undesirable drug effects.
Product Monograph Master Template Template Date:
September 2020 IMODIUM® Complete Loperamide Hydrochloride / Simethicone Tablets Page 12 of 26 Unclassified / Non classifié
There is no evidence of any dependence potential for simethicone. Hepatic/Biliary/Pancreatic Patients with hepatic dysfunction should be monitored for signs of central nervous system (CNS) toxicity due to the extensive first pass metabolism of loperamide in the liver.
IMODIUM® Complete must be used with caution in patients with hepatic impairment as it may result in a relative overdose leading to CNS toxicity. Immune HIV-infected patients treated with Loperamide hydrochloride/Simethicone for diarrhea should have therapy stopped at the earliest signs of abdominal distension.
There have been isolated reports of obstipation with an increased risk for toxic megacolon in AIDS HIV-infected patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride. Neurologic Loperamide hydrochloride/Simethicone should be used with special caution in young children and those with compromised blood brain barrier (eg, meningitis) because of the greater variability of response in these groups.
Dehydration, particularly in young children, may further influence the variability of response to Loperamide hydrochloride/Simethicone. Renal Since the majority of loperamide is metabolized, and metabolites or the unchanged drug is excreted in the feces, dose adjustments in patients with a kidney disorder are not required.
1 Pregnant Women Safe use of Loperamide hydrochloride/Simethicone during pregnancy has not been established. Reproduction studies performed with loperamide hydrochloride in the rat and the rabbit revealed no evidence of impaired fertility or harm to the fetus at dosage levels up to 30-fold the therapeutic dose for man.
Therefore, Loperamide hydrochloride / Simethicone should be used in pregnant women only when, in the opinion of the physician, the potential benefits outweigh the potential risks. Although there are no indications that loperamide or simethicone possess teratogenic or embryotoxic properties, the anticipated therapeutic benefits should be weighed against potential hazards before Loperamide hydrochloride/Simethicone is given during pregnancy, especially during the first trimester.
2 Breast-feeding Small amounts of loperamide may appear in human breast milk. Therefore, Loperamide hydrochloride/Simethicone is not recommended during breast-feeding. 3 Pediatrics Pediatrics (<12 years of age): The use of Loperamide hydrochloride/Simethicone is not recommended for children under 12 years of age except on the advice of a physician.
See DOSAGE AND ADMINISTRATION. Loperamide hydrochloride/Simethicone should be used with special caution in young children because of the greater variability of response in these groups. Dehydration, particularly in young children, may further influence the variability of response to Loperamide hydrochloride/Simethicone.
In patients with (severe) diarrhea, especially in children, fluid and electrolyte depletion may occur. In such cases administration of appropriate fluid and electrolyte replacement should be considered. Loperamide hydrochloride/Simethicone should not be given to children under 6 years of age without medical prescription and supervision.
Loperamide hydrochloride/Simethicone is contraindicated for use in children under 2 years of age.
• IMODIUM® Complete should not be used in patients who have difficulty swallowing.